Medical device and technique for using the same

ABSTRACT

An inflatable balloon cuff may be adapted to seal a patient&#39;s trachea when associated with an endotracheal tube. These cuffs may include indicia that facilitate attachment of the cuff relative to the tube to reduce manufacturing variability for such characteristics as rotational and length alignment. Such indicia may include protrusions that are formed in the wall of the cuff collars or may include visual indicators, e.g., colorimetric or shape-wise indicators. Cuffs with improved attachment relative to the tube may have increased sealing performance.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.12/362,214, filed on Jan. 29, 2009, the disclosure of which is herebyincorporated by reference in its entirety for all purposes.

BACKGROUND

The present disclosure relates to medical devices, and moreparticularly, to airway products, such as tracheal tubes and cuffs.

This section is intended to introduce the reader to various aspects ofart that may be related to various aspects of the present disclosure,which are described and/or claimed below. This discussion is believed tobe helpful in providing the reader with background information tofacilitate a better understanding of the various aspects of the presentdisclosure. Accordingly, it should be understood that these statementsare to be read in this light, and not as admissions of prior art.

In the course of treating a patient, a tube or other medical device maybe used to control the flow of air, food, fluids, or other substancesinto the patient. For example, medical devices such as tracheal tubesmay be used to control the flow of one or more substances into or out ofa patient. In many instances it is desirable to provide a seal betweenthe outside of the tube or device and the interior of the passage inwhich the tube or device is inserted. In this way, substances can onlyflow through the passage via the tube or other medical device, allowinga medical practitioner to maintain control over the type and amount ofsubstances flowing into and out of the patient.

For example, tracheal tubes may be used to control the flow of air orother gases through a patient's trachea. Such tracheal tubes may includeendotracheal (ET) tubes, tracheostomy tubes, or transtracheal tubes. Toseal these types of tracheal tubes, an inflatable cuff may be associatedwith these tubes. When inflated, the cuff generally expands into thesurrounding trachea to seal the tracheal passage around the tube.

Typically, cuffs are attached to tracheal tubes via an adhesive or by aheat bonding process. Because the cuffs are generally made from arelatively thin and flexible material, the cuffs may be distorted duringthe attachment process. For example, the cuffs may be twisted along theaxis of the tube and attached to the tube in a twisted position. Atwisted cuff may have an irregular inflation shape that may lead todecreased sealing efficiency or an increased incidence of wrinkling,whereby the wrinkles may create a “corkscrew” effect. In addition, acuff may be compressed or stretched along the axis of the tube beforebeing sealed to the tube, which may lead to a cuff that is improperlyplaced relative to the tube and that may have decreased sealingperformance. For example, a relatively stretched cuff may have morepronounced wrinkles, which may serve as leak paths into the lungs forsecretions that form at the top of the cuff. A relatively compressedcuff may have too much cuff material which will form many wrinkles wheninflated and, therefore, may provide a decreased seal quality and alsoincreases the risk that secretions will leak past the cuff into thelungs. Such secretions often contain micro-organisms that, uponaspiration by the patient, can result in complications. There remains aneed in the art for an improved cuff and means of mounting the cuff to atracheal tube that may enhance sealing performance and inhibitaspiration of secretions.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the disclosure may become apparent upon reading thefollowing detailed description and upon reference to the drawings inwhich:

FIG. 1 illustrates an endotracheal tube with an inflatable balloon cuffwith indicators on distal and proximal collar regions in the cuff inaccordance with embodiments;

FIG. 2 illustrates an exemplary balloon cuff in a twisted conformationprior to being correctly adhered to a tube according to embodiments;

FIG. 3A illustrates the balloon cuff of FIG. 2 with the indicatorsaligned along an X-ray line on the tube;

FIG. 3B is a cross-sectional view of the cuff and tube of FIG. 3A;

FIG. 4 illustrates an exemplary balloon cuff in a compressedconformation prior to being correctly adhered to a conduit according toembodiments;

FIG. 5 illustrates an exemplary balloon cuff with indicators beingaligned against a mandrel inserted through the interior of the tubeaccording to embodiments;

FIG. 6 illustrates an exemplary balloon cuff with indicators beingaligned against corresponding protrusions on the tube;

FIG. 7 depicts an embodiment of a balloon cuff with shaped protrusions;

FIG. 8 depicts an embodiment of a balloon cuff with multiple protrusionson the proximal and distal opening regions respectively;

FIG. 9 illustrates an embodiment of a balloon cuff associated with aconduit adapted to suction secretions from the top of the cuff; and

FIG. 10 depicts an exemplary mold for forming protrusions on the ballooncuff.

DETAILED DESCRIPTION

One or more specific embodiments of the present disclosure will bedescribed below. In an effort to provide a concise description of theseembodiments, not all features of an actual implementation are describedin the specification. It should be appreciated that in the developmentof any such actual implementation, as in any engineering or designproject, numerous implementation-specific decisions must be made toachieve the developers' specific goals, such as compliance withsystem-related and business-related constraints, which may vary from oneimplementation to another. Moreover, it should be appreciated that sucha development effort might be complex and time consuming, but wouldnevertheless be a routine undertaking of design, fabrication, andmanufacture for those of ordinary skill having the benefit of thisdisclosure.

It is desirable to provide a medical balloon, such as an endotrachealcuff or other medical balloon, that may efficiently seal the passage inwhich the cuff is inserted so that mechanical ventilation can be used tointroduce air, oxygen, other gases, or medications into the lungs.Provided herein are balloon cuffs with features that allow an operatoror automatic quality system to align a cuff against a tracheal tube tominimize stretching, compressing, twisting, or out of specificationaxial placement of the cuff relative to the tube. Such cuffs may includeraised protrusions or other markers on the wall of the cuff that mayserve as alignment indicators for aligning the cuff against the tube.

Medical cuffs as provided herein may be used in conjunction with anysuitable medical device. Preferably, the medical cuffs as providedherein may be used in conjunction with an endotracheal tube, atracheostomy tube, a circuit, an airway accessory, a connector, anadapter, a filter, a humidifier, a nebulizer, or a prosthetic. Medicalcuffs as provided herein may include those as disclosed in “MEDICALDEVICE AND TECHNIQUE FOR USING THE SAME,” by Macan, et al., filed onJan. 29, 2009, which is incorporated by reference herein in its entiretyfor all purposes.

Provided herein is an exemplary cuffed endotracheal tube 10, depicted inFIG. 1. The cuffed endotracheal tube 10 includes an inflatable medicalcuff 12 that may be inflated to form a seal against the trachea wall.The medical cuff 12 is disposed on an endotracheal tube 16, which is aconduit that is suitably sized and shaped to be inserted into a patientand allow the passage of air through the airway path of the endotrachealtube 16. Typically, the cuff is disposed, adhesively or otherwise,towards the distal end 17 of the endotracheal tube 16. The medical cuff12 may, for example, be inflated and deflated via a lumen 14 incommunication with the medical cuff 12, typically through a hole ornotch 15 in the endotracheal tube 16. The medical cuff 12 includes aproximal collar region 20 and a distal collar region 22 formed in thecuff walls and sized to accommodate the endotracheal tube 16. Theproximal collar 20, located closer to the “machine end” of the tube 16,and a distal collar 22, located closer to the “patient end” of the tube16, are typically used to mount the cuff 12 to the tube 16. The collarregions 20 and 22 flank an inflatable region 24, which is in fluidcommunication with lumen 14. In embodiments, the cut edges of the cuff12 may be used to position the cuff 12 relative to other features on thetube (e.g., tube tip, Murphy eye).

The medical cuff 12 may be formed from materials having suitablemechanical properties (such as puncture resistance, pin hole resistance,tensile strength), chemical properties (such as forming a suitable bondto the tube 16), and biocompatibility. In one embodiment, the walls ofthe inflatable cuff 12 are made of a polyurethane having suitablemechanical and chemical properties. An example of a suitablepolyurethane is Dow Pellethane® 2363-90A. In another embodiment, thewalls of the inflatable cuff 12 are made of a suitable polyvinylchloride (PVC). Other suitable materials include polypropylene,polyethylene teraphthalate (PETP), low-density polyethylene (LDPE),silicone, neoprene, polyisoprene, or polyurethane (PU).

The cuff 12 also may include alignment indicia or indicators 26 and 28,which may be indicators of any type, including text, image, ink,chemical, or topographic markers. Further, although only indicia 26 and28 are shown, it should be understood that any suitable number ofalignment indicators may be present. Further, each indicator, e.g., 26and/or 28, may include multiple markings or members. For example, analignment indicator may include a group of dots. As shown, indicator 26and indicator 28 are associated with the proximal collar 26 and thedistal collar 28, respectively. In an embodiment, the alignment indicia26 and 28 may be raised protrusions. The indicia 26 and 28 may be partof the cuff wall material and may be formed in the proximal collar 20and distal collar 22 regions formed in the cuff wall. Alternatively, theindicia 26 and 28 may be adhesively or otherwise attached to the cuffmaterial after assembly of the cuff 12. The indicia 26 and 28 may besized and shaped in any suitable configuration that does notsubstantially prevent the proximal collar region 20 and the distalcollar region 22 from adequately sealing to the tube 16. In embodiments,the indicia may be raised relative to the cuff walls at least enough foran operator to feel them with a fingertip, to see them with a naked eyeor under magnification (e.g., illuminated magnification), or for amachine to sense them optically or by other modalities. In embodiments,the indicia are raised relative to the proximal collar 20 or distalcollar 22 at least about 0.1 mm, at least about 0.125 mm, at least about0.5 mm, at least about 1 mm, at least about 2 mm, or at least about 3mm. In addition, the indicia may be raised on the exterior surface ofthe cuff collars, i.e., the tracheal-facing surface. In addition, theindicia may be raised relative to the interior, i.e., the tube adhesionsurface of the cuff collars. In such embodiments, when the cuff 12 ispressed against the tube 16, the raised portions may also be pushedagainst the tube 16 when the cuff 12 is adhered to the tube 16.

In an embodiment, a colored ink may be used to form all or part of analignment indicator or to emphasize the features of a protrusion againstthe cuff 12. In other embodiments, chemical tags may be used to form thealignment indicator. For example, a UV light may be used to visualizealignment indicators that include UV or fluorescent paints.

The alignment indicators (e.g., indicators 26 and 28) may be used tocheck cuff length and cuff twisting relative to the tube 16. Because thepositions of the proximal collar 20 and distal collar 22 regions do notchange substantially with the inflation state of the cuff 12, alignmentindicators in these regions may be used to check cuff applicationquality in both inflated and uninflated cuffs. Specifically, becausethese opening regions 20 and 22 may be substantially adhered to the tube16, during an inflation spot check the protrusions in these regionsmaintain close contact with the exterior surface (i.e., trachealwall-facing surface) of the tube 16. Accordingly, indicators 26 and 28,such as protrusions, may be more easily aligned against markers on thetube 16 than any marker in the inflated region 24, which is generallynot in close proximity to the surface of the tube 16.

FIG. 2 shows an exemplary cuff 12 applied to a tube 16 for an inflationspot-check prior to final adhesion of the cuff 12 to the tube 16. Asshown, the cuff 12 is twisted, and a proximal indicator 26 and distalindicator 28, depicted as protrusions, are not aligned along animaginary axis 30 extending through one of the indicators, for example,extending from indicator 26 as shown in FIG. 2, and running along thelength of the tube 16. The twisted conformation of the cuff 12 mayprevent full inflation of the cuff 12 within the trachea, which may leadto inefficient sealing. In addition, the twisted conformation mayincrease the formation of wrinkles 32 in the cuff 12, which may in turnincrease the availability of leak paths from the top of the cuff intothe lungs. Accordingly, the rotation of the cuff 12 relative to the tube16 may need to be altered prior to adhering the cuff 12. Themisalignment of indicators 26 and 28 may be spotted by an operatormanually applying the cuff 12 to the tube 16. Alternatively, the qualitycontrol may be performed by a machine capable of sensing a thickness inthe cuff material or a visual marker at the site of each indicator(e.g., indicators 26 and 28) and either alerting the operator to themisalignment or automatically aligning the indicators along the tubelength based on the sensed cuff material thickness. In an embodiment,the indicators may include a marker that may be imaged by a machine toassist in locating the indicators on the cuff 12 prior to alignment. Forexample, the markers may include color markers, fluorescent markers, orultraviolet light-visible markers, that, when imaged, may be manually orautomatically identified to provide an indication of cuff alignmentand/or placement.

In another embodiment, turning to FIG. 3A, the cuff 12 may be alignedrelative to the tube 16 by other features on the tube 16. In oneembodiment, the feature may be an X-ray line 36 that is marked on thetube 16, for example by a radio opaque color, and runs along the lengthof tube 16. The X-ray line may serve to provide an indication of thelocation of the tube 16 during X-ray visualization. In an embodiment,the X-ray line 36 may also provide the manufacturing tolerance for therotational alignment. For example, the manufacturing tolerance may bethat both indicators 26 and 28 must be touching the X-ray line 36. Insuch embodiments, the effective manufacturing tolerance is the width ofthe X-ray line 36. For example, in an embodiment, the manufacturingtolerance may be equal to or less than a certain angle offset of theindicators. Such an offset angle 33 may be determined by examining thealignment of indicators 26 and 28 as viewed through a cross-section ofthe tube 16, as shown in FIG. 3B. In FIG. 3B, indicators 26 and 28 aretouching the X-ray line 32 and are, thus, within a manufacturingtolerance. The offset angle 33 may be, in embodiments, equal to or lessthan 37°, equal to or less than 30°, or equal to or less than 27. Inaddition, the offset angle 33 tolerance may be different depending onthe size or shape of the cuff 12. In other embodiments, themanufacturing tolerance may be indicated on the tube by additionalalignment markers. For example, in one embodiment, a dedicated alignmentline having a different placement and/or width than the X-ray line 36may be marked on the tube 16. In an embodiment, the line may be adifferent color than the X-ray line 36, for example, the X-ray line 36may be marked in blue while the alignment line may be pink or green.

In addition to rotational alignment, a cuff 12 may be aligned withrespect to its length along the tube 16. FIG. 4 illustrates a ballooncuff that is in an incorrect compressed conformation prior to beingadhered to a conduit. When applying a typical cuff 12 to the tube 16, anoperator may align the proximal collar 20 to a location on the tube 16directly above notch 15 so that the inflatable region 24 is in fluidcommunication with the lumen 14. However, the distal collar 22 may thenbe applied to the tube 16 intuitively by the operator. That is, theoperator uses personal experience to guess at a correct cuff length.This may lead to variability in the cuff length based on the experiencelevel of the operator. Accordingly, using this method, a higher numberof cuffs 12 may be outside of a cuff length manufacturing tolerance,e.g., about 2.1 inches to about 2.3 inches or about 53 mm to about 58.4mm, which may lead to waste as these cuffed tubes are discarded at laterstages in the manufacturing process. In addition, quality checkingprocedures may include a direct measurement of cuff length with a ruler,which may be time-consuming and challenging because both the cuff 12 andthe tube 16 are relatively transparent and may be difficult todifferentiate from one another at the adhesion regions of the cuff 12.

In embodiments, cuffs 12 as provided may be easily checked for relativelength against the tube 16. FIG. 5 illustrates a cuff 12 being checkedfor length by aligning markers on the cuff 12 with markers on analignment rod 40 (e.g., a mandrel) inserted through the flow path oftube 16. The rod 40 may include alignment lines 42 and 44 that may bealigned with indicators 26 and 28 as shown. Alignment lines 42 and 44may be brightly colored to facilitate rapid spot checks of the cufflength. The alignment lines 42 and 44 may be set to reflect themanufacturing cuff length goal, with a tolerance being built into thewidth of these lines. For example, the tolerance may be met if bothindicators 26 and 28 are at least touching their respective lines 42 and44. In an embodiment, the cuff rotational alignment may be performedsimultaneously with the cuff length alignment while the rod 40 isinserted in the tube 16. In embodiments in which the rod 40 issubstantially rigid, the slightly curved tube 16 may be straightenedupon insertion of the rod 40, which may allow operators to more easilyperform fine rotational alignment of indicator 26 with indicator 28along the length of tube 16. In other embodiments, the cuff length maybe verified with a ruler, a caliper, or a go/no-go gauge.

While operators may employ alignment accessories, such as rod 40, inassisting with length alignment of the cuff 12, the tube 16 may, inembodiments, also include indicators or features that may be used toalign the cuff 12 with respect to length in addition to rotationalalignment (e.g., the X-ray line depicted in FIG. 3). For example, a tube16 may include indicators that may be aligned with markers on the cuff12. As shown in FIG. 6, a tube 16 may include proximal protrusion 50 anddistal protrusion 52 which may be aligned to proximal indicator 26 anddistal indicator 28, shown here as protrusions. Such shaped or visualalignment features on both the tube 16 and the cuff 12 may be aligned byboth feel and/or sight by the operator, which may improve the ease andaccuracy of the alignment.

In embodiments, a cuff 12 may be bi-directional, i.e., the cuff 12 maybe generally symmetric along an axis perpendicular to an axis throughproximal collar 20 and distal collar 22 at the midpoint of the cufflength along the tube 16. In such embodiments, the distal collar 20 maybe applied to the proximal adhesion point of the tube and vice versa.However, in certain embodiments, a cuff 12 may be unidirectional and mayhave a specified orientation along the tube. For example, FIG. 7 depictsan embodiment of an endotracheal tube with a tapered balloon cuff 63 inwhich the widest diameter is located towards the proximal end of thecuff 63. Because cuffs 12 may be applied to the tube 16 prior toinflation, it may be difficult to determine which end of the taperedcuff 63 is the proximal collar 20 while the cuff 63 is in the uninflatedstate because the direction of the taper may not be evident when thetapered cuff 63 is uninflated. As provided herein, a tapered cuff 63 mayinclude a proximal marker 60 that is different than a distal marker 62that may facilitate the application of the proximal collar 20 to theproximal cuff adhesion point of the tube 16. An operator may easilydetermine in which direction the cuff 63 should be oriented by observingshaped proximal marker 60, which as shown, may be in a “+” shape, versusshaped distal marker 62, which may be in a “−” shape. Any suitablecombination of shaped protrusion or colored markers may be used. Forexample, proximal marker 60 may be green while distal marker 62 may bered and so forth. In other embodiments, a combination of shapedprotrusions and colors may be used.

While alignment indicators as provided herein may be used by an operatorin manually applying cuffs 12 to tubes 16, it is envisioned that thepresent embodiments may also be used with automatic alignment asperformed by a machine or assembly system. FIG. 8 is an embodiment of aballoon cuff with multiple indicators, depicted as protrusions, on theproximal and distal opening regions 20 and 22, respectively. Forexample, such an embodiment may be advantageous for use with an assemblymachine that may provide attachment arms 70 with pincer grips 72 thatmay grip the cuff 12 at indicators 26 a and 26 b on the proximal end ofthe cuff 12 and at 28 a and 28 b at the distal end of the cuff 12. Thelocation of the indicators 26 a, 26 b and 28 a, 28 b may facilitateproper gripping of the cuff 12 by the assembly machine prior toalignment, e.g., the indicators 26 a, 26 b and 28 a, 28 b may provideattachment or gripping positions at which the pincer grips 72 are ableto hold the cuff 12. In such an embodiment, the alignment may then beperformed by aligning the arms relative to one another at the properlength and rotation.

It is envisioned that the balloon cuffs 12 as provided may be used inconjunction with any suitable tracheal tube. FIG. 9 illustrates anembodiment of a balloon cuff associated with a tracheal tube 80 that isadapted to suction secretions from the top of the cuff. The endotrachealtube 80 includes a secretion lumen 82 that has a hole 84 located above(“proximal to”) the proximal shoulder of cuff 12. The proximal collar 20may be sealed to the tube 16 in a manner designed to move the hole 84relative to the proximal collar 20 of the cuff 12 to facilitateaspiration of secretions that build up on this shoulder region, whichmay act like a shelf. While certain cuffs 12 may be aligned in aninflated state, and then adhered the tube 16, cuffs 12 for use with sucha secretion lumen may also be aligned in an uninflated state, asdescribed herein, prior to applying the specialized seal of the proximalcollar region 20 to the tube 16. For example, the proximal collar region20 may be shortened, either by initial design or by folding the collarregion itself or the cuff wall material to decrease the distance betweenthe cuff 12 and hole 84.

The cuffs 12 as provided may be manufactured by any suitable process,such as by blow molding. In one example, a tube, such as an extrudedpolyurethane tube, is loaded into a blowing machine or mold assembly,such as a cross-section of a mold assembly 90, depicted in FIG. 10, thatincludes dowels or shapes 92 and 94 in the mold corresponding to thedesired shape of the alignment indicators 26 and 28, e.g., protrusions,depressions. In an embodiment, shapes 92 and 94 may include injectionorifices for the injection of colored markers or chemical tags to assistin visualization of the alignment indicators. In one embodiment, themold assembly 90 is manufactured from beryllium copper and includes ahorizontal split in the assembly 90 to allow opening and closing of themold assembly 90. In an embodiment, the mold assembly 90 may includemating symmetrical pieces that close together. The mold assembly 90 mayinclude integrated guide pins to prevent misalignment of the two moldhalves. In one embodiment, the end-portions of an extruded tube thatproject out from the mold are constrained to the shape and thickness ofthe original extruded tube by non-heat transferrable plastic holders atthe ends of the mold. In one embodiment, the blow molders are model2219H-LP blow molding machines, available from Interface Associates,that are configured to run at 1-2 bars of gas pressure. In embodimentsin which the indicators (e.g., indicators 26 or 28) may comprise shapedprotrusions, the protrusions may be formed by allowing extra flash alongthe mold 90 parting line.

Once loaded, the mold assembly 90 is closed, and the tube is clamped ateach end. The mold 90 may then be heated. The tube may be stretched andair is blown into the tube via an air conduit, such as an air hose ornozzle, connected to a source of pressurized air, such as an air pump orpre-pressurized source, to achieve a desired positive pressure withinthe tube and to blow out the cuff walls to the shape of the moldassembly 90. Additional heat may be applied to the tube, such as viaheating elements integral to the mold assembly to set the shape of thecuff 12. As the heat is applied, the stretch of the tube is relaxed andthe air pressure within the tube is increased. Once the desiredtemperature is reached it is maintained for an interval of time.Afterward, the temperature of the mold assembly is allowed to drop or isactively cooled. A vacuum is applied within the tube, which now includesthe blown cuff, to release the tube and cuff from the mold assembly andthe tube and cuff are removed from the mold assembly.

For example, in one embodiment, a commercially available extrusion ofDow Pellethane® 2363-90AE having an inner diameter of 0.239±0.005 inches(6.0706±0.127 mm) and a wall thickness of 0.015 mm±0.007 mm may be blownto form a cuff 12 suitable for use with a 7.5 mm internal diameter (ID)endotracheal tube. The extruded tube may be cooled to room temperatureand, when set, inserted into the mold assembly 90 automatically or byhand. Once loaded, the mold may be fitted into a sleeve of ablow-molding machine. The sleeve may be heated, such as by a series often electrical cartridges surrounding the sleeve, thereby heating themold. In this embodiment, the mold may be heated to approximately 50° C.prior to stretching or blowing the extruded tube.

An air chuck locks on to one end of the extruded tube while the otherend of the extruded tube if sealed by a clamp to create an airtightseal. The extruded tube is stretched by pulling on both ends of the tubeand, while stretching, nitrogen or another suitable gas or gas mixtureis into the extruded tube via the air chuck to pressurize the tube tobetween about 1 to about 3 bars. In one embodiment, the balloon willform in the portion of the tube situated within the mold when the tubeexpands under pressure to make contact with the internal walls of themold.

When the cuff is fully blown against the inner walls of the mold, themold may be heated (such as by heating the surrounding sleeve) tobetween about 100° C. to about 150° C. and this temperature may bemaintained for between about 10 to about 30 seconds. After theapplication of heat, the mold may be cooled to approximately 45° C.,such as by pumping refrigerated water at approximately 13° C. around themold, to set the cuff. A vacuum is applied to the molded extrusion andcuff, and the extrusion and cuff are removed from the mold assembly.

The indicators, e.g., protrusions, on the wall of the cuff may serve asguides for cutting each cuff 12 during the manufacturing process. Forexample, after the cuff 12 is formed in a blow molding apparatus, thecuff 12 may be ready to be cut out from a longer extruded tube by alaser cutting machine. The laser may be set so that when a guide isfocused on the protrusions, the cut is made at an appropriate distancefrom a proximal indicator 26 and a distal indicator 28. By using theindicators as guides, each cuff 12 may be a more uniform length.

The cuff 12 may be applied to the tube 16, which may be, for example, anextruded PVC conduit, by any suitable process. In one embodiment, thetube 16 may be inserted onto a rotating mandrel, and an operator mayinsert a gluing needle under the surface of the proximal collar 20 andthe distal collar 22 of the cuff 12 to dispense the glue evenly.

The tracheal cuffs of the present techniques may be incorporated intosystems that facilitate positive pressure ventilation of a patient, suchas a ventilator. Such systems may typically include connective tubing, agas source, a monitor, and/or a controller. The controller may be adigital controller, a computer, an electromechanical programmablecontroller, or any other control system.

Typically, endotracheal cuffs are inflated within a patient's tracheasuch that the intra cuff pressure is approximately 20-25 cm H₂O.Endotracheal cuffs utilizing inflation pressures significantly greaterthan 25 cm H₂O may be referred to as high-pressure cuffs, while cuffsthat are able to effectively seal the trachea at pressures less than 30cm H₂O may be considered low-pressure cuffs. In certain embodiments,intra cuff inflation pressures of 10-30 cm H₂O may be used with themedical cuffs of the present techniques.

While the disclosed embodiments may be susceptible to variousmodifications and alternative forms, specific embodiments have beenshown by way of example in the drawings and have been described indetail herein. However, it should be understood that the disclosure isnot intended to be limited to the particular forms disclosed. Rather,the disclosure is to cover all modifications, equivalents, andalternatives falling within the spirit and scope of the disclosedembodiments as defined by the following appended claims.

What is claimed is:
 1. A method of manufacturing a tracheal tubecomprising: passing a conduit through a proximal collar and a distalcollar in a wall of the balloon cuff; and aligning a first indicator onthe proximal collar with a second indicator on the distal collar,wherein the first indicator is disposed about only a portion of acircumference of the proximal collar that is affixed to the conduit; andwherein the second indicator is disposed about only a portion of acircumference of the distal collar that is affixed to the conduit. 2.The method of claim 1, comprising aligning the first indicator and thesecond indicator along a set length of the conduit.
 3. The method ofclaim 1, wherein aligning the first indicator and the second indicatoralong the set length of the conduit comprises inserting a rod throughthe conduit, wherein the rod comprises at least one alignment markercorresponding to the first indicator or the second indicator.
 4. Themethod of claim 3, wherein aligning the first indicator and the secondindicator along the set length of the conduit comprises aligning thefirst indicator or the second indicator to a mark or feature on theconduit.
 5. The method of claim 1, wherein the first indicator and thesecond indicator are not identical.
 6. The method of claim 1, wherein atleast one of the first indicator or the second indicator comprises aprotrusion or depression.
 7. The method of claim 1, wherein at least oneof the first indicator or the second indicator comprises text or animage.
 8. The method of claim 1, wherein the conduit comprises one ormore X-ray lines that run along at least a portion of the length of theconduit and wherein aligning the first indicator and the secondindicator comprises alignment with at least one of the X-ray lines.
 9. Amethod of applying an inflatable balloon cuff to a conduit comprising:passing a conduit through a proximal collar and a distal collar in awall of the balloon cuff; and aligning a first indicator on the proximalcollar with a second indicator on the distal collar along a set lengthof the conduit, wherein the alignment is substantially along an axisextending through the first indicator and the second indicator along thelength of the conduit, and the alignment comprises inserting a rodthrough the conduit, wherein the rod comprises at least one alignmentmarker corresponding to the first indicator or the second indicator.